VA/DoD CLINICAL PRACTICE GUIDELINE FOR DIAGNOSIS AND TREATMENT OF LOW BACK PAIN

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DIAGNOSIS AND TREATMENT OF LOW BACK PAIN

Department of Veterans Affairs Department of Defense

QUALIFYING STATEMENTS

The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision making. They are not intended to define a standard of care and should not be construed as one. Neither should they be interpreted as prescribing an exclusive course of management.

This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological evidence.

Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical relationships between various care options and health outcomes while rating both the quality of the evidence and the strength of the recommendation.

Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every healthcare

professional making use of these guidelines is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation.

These guidelines are not intended to represent Department of Veterans Affairs or TRICARE policy. Further, inclusion of recommendations for specific testing and/or therapeutic interventions within these guidelines does not guarantee coverage of civilian sector care. Additional information on current TRICARE benefits may be found at www.tricare.mil or by contacting your regional TRICARE Managed Care Support Contractor.

Version 2.0 – 2017

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Prepared by:

The Diagnosis and Treatment of Low Back Pain Work Group

With support from:

The Office of Quality, Safety and Value, VA, Washington, DC

&

Office of Evidence Based Practice, U.S. Army Medical Command

Version 2.0 – 2017

Based on evidence reviewed through October 21, 2016

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I. Introduction

The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the “…Health

Executive Council on the use of clinical and epidemiological evidence to improve the health of the population across the Veterans Health Administration and Military Health System,” by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations.[1] This CPG is intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the individual needs and preferences of patients with low back pain (LBP).

In 2007, the VA and DoD published the Clinical Practice Guideline for diagnosis and treatment of Low Back Pain (2007 LBP CPG), which was based on evidence reviewed through November 2006. Since the release of that guideline, a growing body of research has expanded the general knowledge and understanding of LBP.

Improved recognition of the complex nature of these conditions has led to the adoption of new strategies for diagnosis and treatment of LBP.

Consequently, a recommendation to update the 2007 LBP CPG was initiated in 2016. The updated CPG, titled Clinical Practice Guideline for Diagnosis and Treatment of Low Back Pain (2017 LBP CPG), includes objective, evidence-based information on the diagnosis and management of acute and chronic LBP. It is intended to assist healthcare providers in all aspects of patient care, including, but not limited to, diagnosis, treatment, and management. The system-wide goal of this guideline is to improve the

patient’s health and wellbeing by providing evidence-based guidance to providers who are diagnosing or treating patients with LBP. The expected outcome of successful implementation of this guideline is to:

• Assess the patient’s condition and determine, in collaboration with the patient, the best treatment method

• Optimize each individual’s health outcomes and improve quality of life

• Minimize preventable complications and morbidity

• Emphasize the use of patient-centered care

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II. Recommendations

# Recommendation Strength* Category†

A. Diagnostic Approach

1. For patients with low back pain, we recommend that clinicians conduct a history and physical examination, that should include identifying and evaluating neurologic deficits (e.g., radiculopathy, neurogenic claudication), red flag symptoms associated with serious underlying pathology (e.g., malignancy, fracture, infection), and psychosocial factors.

Strong for Reviewed, Amended

2. For patients with low back pain, we suggest performing a mental health screening as part of the low back pain evaluation and taking results into consideration during selection of treatment.

Weak for Reviewed, New-replaced 3. For patients with acute axial low back pain (i.e., localized, non-radiating), we

recommend against routinely obtaining imaging studies or invasive diagnostic tests.

Strong

against Reviewed, Amended 4. For patients with low back pain, we recommend diagnostic imaging and

appropriate laboratory testing when neurologic deficits are serious or progressive or when red flag symptoms are present.

Strong for Reviewed, Amended 5. For patients with low back pain greater than one month who have not improved

or responded to initial treatments, there is inconclusive evidence to recommend for or against any diagnostic imaging.

applicable Not Reviewed, New-added B. Education and Self-care

6. For patients with chronic low back pain, we recommend providing evidence- based information with regard to their expected course, advising patients to remain active, and providing information about self-care options.

Strong for Reviewed, Amended 7. For patients with chronic low back pain, wesuggest adding a structured

education component, including pain neurophysiology, as part of a multicomponent self-management intervention.

Weak for Reviewed, New-added C. Non-pharmacologic and Non-invasive Therapy

8. For patients with chronic low back pain, we recommend cognitive behavioral

therapy. Strong for Reviewed,

New-replaced 9. For patients with chronic low back pain, we suggest mindfulness-based stress

reduction. Weak for Reviewed,

New-replaced 10. For patients with acute low back pain, there is insufficient evidence to support

the use of specific clinician-directed exercise. Not

applicable Reviewed, New-replaced 11. For patients with chronic low back pain, we suggest offering clinician-directed

exercises. Weak for Reviewed,

New-replaced 12. For patients with acute or chronic low back pain, we suggest offering spinal

mobilization/manipulation as part of a multimodal program. Weak for Reviewed, New-replaced 13. For patients with acute low back pain, there is insufficient evidence to support

the use of acupuncture. Not

applicable Reviewed, New-replaced 14. For patients with chronic low back pain, we suggest offering acupuncture. Weak for Reviewed,

New-replaced 15. For acute or chronic low back pain, there is insufficient evidence for or against

the use of lumbar supports. Not

applicable Reviewed, Amended 16. For patients with chronic low back pain, we suggest offering an exercise

program, which may include Pilates, yoga, and tai chi. Weak for Reviewed, New-replaced 17. For patients with low back pain, there is insufficient evidence to support the use

of ultrasound. Not

applicable Reviewed, New-added

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18. For patients with low back pain, there is inconclusive evidence to support the use

of transcutaneous electrical nerve stimulation (TENS). Not

applicable Reviewed, New-added 19. For patients with low back pain, there is insufficient evidence to support the use

of lumbar traction. Not

applicable Reviewed, New-added 20. For patients with low back pain, there is insufficient evidence to support the use

of electrical muscle stimulation. Not

applicable Reviewed, New-added D. Pharmacologic Therapy

21. For patients with acute or chronic low back pain, we recommend treating with

nonsteroidal anti-inflammatory drugs, with consideration of patient-specific risks. Strong for Reviewed, Amended 22. For patients with chronic low back pain, we suggest offering treatment with

duloxetine, with consideration of patient-specific risks. Weak for Reviewed, New-added 23. For patients with acute low back pain or acute exacerbations of chronic low back

pain, we suggest offering a non-benzodiazepine muscle relaxant for short-term use.

Weak for Reviewed, New-added 24. For patients with chronic low back pain, we suggest against offering a non-

benzodiazepine muscle relaxant. Weak

against Reviewed, New-added 25. For patients with low back pain, we recommend against benzodiazepines. Strong

against Reviewed, New-replaced 26. For patients with acute or chronic low back pain with or without radiculopathy,

we recommend against the use of systemic corticosteroids (oral or intramuscular injection).

Strong

against Reviewed, Amended 27. For patients with low back pain, we recommend against initiating long-term

opioid therapy. For patients who are already prescribed long-term opioid therapy, refer to the VA/DoD CPG for the Management of Opioid Therapy for Chronic Pain.¹

Strong

against Reviewed, New-replaced

28. For patients with acute low back pain or acute exacerbations of chronic low back pain, there is insufficient evidence to recommend for or against the use of time- limited opioid therapy. Given the significant risks and potential benefits of opioid therapy, patients should be evaluated individually, including consideration of psychosocial risks and alternative non-opioid treatments. Any opioid therapy should be kept to the shortest duration and lowest dose possible.

applicable Not Reviewed, New-replaced

29. For patients with acute or chronic low back pain, there is insufficient evidence to recommend for or against the use of time-limited (less than seven days)

acetaminophen therapy.

applicable Not Reviewed, New-replaced 30. For patients with chronic low back pain, we recommend against the chronic use

of oral acetaminophen. Strong

against Reviewed, New-replaced 31. For the treatment of acute or chronic low back pain, including patients with both

radicular and non-radicular low back pain, there is insufficient evidence to recommend for or against the use of antiepileptics including gabapentin and pregabalin.

applicable Not Reviewed, New-replaced

32. For the treatment of low back pain, there is insufficient evidence to recommend

for or against the use of topical preparations. Not

applicable Reviewed, New-added E. Dietary Supplements

33. For the treatment of low back pain, there is insufficient evidence to recommend

for or against nutritional, herbal, and homeopathic supplements. Not

applicable Reviewed, New-added

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F. Non-surgical Invasive Therapy

34. For the long-term reduction of radicular low back pain, non-radicular low back pain, or spinal stenosis, we recommend against offering spinal epidural steroid injections.

Strong

against Reviewed, New-added 35. For the very short-term effect (less than or equal to two weeks) of reduction of

radicular low back pain, we suggest offering epidural steroid injection. Weak for Reviewed, New-added 36. For the treatment of low back pain, we suggest against offering intra-articular

facet joint steroid injections. Weak

against Reviewed, New-added 37. For patients with low back pain, there is inconclusive evidence to recommend for

or against medial branch blocks and radiofrequency ablative denervation. Not

applicable Reviewed, New-added G. Team Approach to Treatment of Chronic Low Back Pain

38. For selected patients with chronic low back pain not satisfactorily responding to more limited approaches, we suggest offering a multidisciplinary or

interdisciplinary rehabilitation program which should include at least one physical component and at least one other component of the biopsychosocial model (psychological, social, occupational) used in an explicitly coordinated manner.

Weak for Reviewed, New-replaced

*For additional information, please refer to Grading Recommendations.

†For additional information, please refer to Recommendation Categorization and Appendix A.

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III. Background

A. Description of Low Back Pain

While LBP is a symptom, rather than a disease or a syndrome, the diagnosis and treatment approaches for most patients with axial/non-radiating (previously referred to as non-specific) LBP is similar regardless of the underlying etiology. Therefore, this CPG focuses mainly on the management of patients with axial/non- radiating LBP rather than specific underlying diagnoses.

LBP is often categorized as acute (pain up to four weeks), subacute (4-12 weeks), or chronic (more than 12 weeks), and as such, the management of patients differs with the duration of the pain (see the Glossary in Appendix D for additional definitions). Axial/non-radiating LBP can be caused by mechanical problems, degenerative disc disease, facet joint arthropathy, or bulging or herniated intervertebral discs.[2] LBP may occur in the presence of radiculopathy or neurogenic claudication. The nature of pain in some patients may be myofascial, a symptom of fibromyalgia, and for some have an important underlying psychological component.

Signs and symptoms that indicate serious underlying pathology requiring additional diagnostic workup and prompt treatment are generally referred to as “red flags.” Table 1 lists some common serious spinal conditions and the red flags that indicate further investigation may be needed.

The various treatments of axial/non-radiating LBP are categorized for this CPG as education and self- care, non-pharmacologic and non-invasive, pharmacologic, dietary supplements, non-surgical invasive procedures, and team approach. Other than surgery, which is out of scope for this CPG, the above-listed therapeutic approaches are discussed in detail in this CPG.

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Table 1: Serious Underlying Conditions for LBP and Associated Red Flags or Risk Factors Possible causes or

conditions Red flags or risk factors on history or physical examination Cancer

 History of cancer with new onset of LBP

 Unexplained weight loss

 Failure of LBP to improve after one month

 Age greater than 50 years

Infection

 Fever

 Intravenous drug use

 Recent infection

 Immunosuppression

Fracture

 History of osteoporosis

 Chronic use of corticosteroids

 Older age (75 years or older)

 Recent trauma

 Younger patients with overuse at risk for stress fracture

Ankylosing spondylitis

 Morning stiffness

 Improvement with exercise

 Alternating buttock pain

 Awakening due to low back pain during the second part of the night (early morning awakening)

 Younger age

Herniated disc

 Radicular back pain (e.g., sciatica)

 Lower extremity dysesthesia and/or paraesthesia

 Positive straight-leg-raise test or crossed straight-leg-raise test

 Severe/progressive lower extremity neurologic deficits

 Symptoms present for more than one month

Spinal stenosis

 Radicular back pain (e.g., sciatica)

 Lower extremity dysesthesia and/or paraesthesia

 Neurogenic claudication

 Older age

 Severe/progressive lower extremity neurologic deficits

 Symptoms present for more than one month

Cauda equina or conus medullaris syndrome

 Urinary retention

 Urinary or fecal incontinence

 Saddle anesthesia

 Changes in rectal tone

 Severe/progressive lower extremity neurologic deficits Abbreviation: LBP: low back pain

B. Epidemiology and Impact

a. General Population

LBP is one of the most frequently experienced medical conditions in the general population, with up to 84% of adults in the United States (U.S.) experiencing LBP at some point in their lives.[3] In 2010, of all diseases and injuries contributing to disability-adjusted life years in the U.S., LBP was ranked third.[4]

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In 2012, approximately 27.5% of adults 18 years and older in the U.S. reported experiencing LBP in the last three months. This was slightly lower than in 1997 (29.2%) and 2010 (28.4%). Additionally, women are more likely than men to experience LBP (29.6% versus 25.4%, respectively).[5] More than two-thirds of pregnant women experience LBP and symptoms typically increase with advancing pregnancy;[6] however, pregnancy-related LBP often resolves itself in the post-partum period and may require specialist care when LBP persists or red flags are present.

In a study of U.S. healthcare costs from 1996 through 2013, spending related to LBP and neck pain was the third highest out of 155 conditions. In 2013, the estimated spending related to LBP and neck pain was $87.6 billion, an increase of $57.2 billion over the past 18 years.[7]

b. Veterans Affairs Population

The National Institutes of Health 2014 National Health Interview Survey provided national prevalence estimates of U.S. Veterans with severe pain (including back pain). The survey showed that 33% of Veterans reported significant back pain in the prior three months. The back pain was axial in 20% of Veterans and had features of sciatica in 12%. Among Veterans with back pain, 22% reported it as severe, and were more likely to have severe back pain compared to Non-Veterans.[8]

c. Department of Defense Population

A study of LBP in U.S. Armed Forces found that LBP diagnoses were associated with over six million outpatient visits and over 25,000 hospitalizations among Active Duty Service Members during the years 2010-2014.[9] The overall annual incidence of LBP was 12.0%. Of patients with LBP, 88.3% received a diagnosis of “non-specific LBP,” but many received more than one diagnosis for LBP, including degenerative changes (14.1%), herniated disc (9.7%), and spinal stenosis (1.8%). A breakdown of the annual incidence of LBP by gender, service, race, and occupation is available in Table 2.[9]

Table 2: Incidence of Low Back Pain in U.S. Armed Forces, 2010-2014[9]

Category Subgroup Rate per year in

percent

Gender Male 11.3%

Female 16.3%

Service

Army 15.8%

Navy 7.9%

Air Force 12.6%

Marine Corps 8.7%

Coast Guard 10.5%

Race

Black, non-Hispanic 13.8%

White, non-Hispanic 11.9%

Other 11.1%

Military Occupation

Combat 10.8%

Healthcare 14.8%

Admin/supply 14.7%

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IV. About this Clinical Practice Guideline

This LBP CPG is intended for VA and DoD healthcare practitioners including physicians, nurse practitioners, physician assistants, physical and occupational therapists, psychologists, social workers, nurses,

chiropractors, clinical pharmacists, and others involved in the care of Service Members and their beneficiaries, retirees and their beneficiaries, or Veterans with LBP.

As with other CPGs, there are limitations, including significant evidence gaps, and a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available through October 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient.

A. Scope of this Clinical Practice Guideline

This LBP CPG is designed to assist healthcare providers in diagnosing or treating patients with LBP. This CPG is not intended for and does not provide recommendations for the diagnosis and treatment of LBP in children or adolescents, or pregnant women. Surgical procedures (including procedures using spinal cord stimulators) are outside the scope of this guideline and excluded from the evidence review. Any patient in the VA or DoD healthcare system should be offered access to the interventions that are recommended in this guideline after taking into consideration the patient’s specific circumstances.

Implementation of this guideline is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non- judgmental approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making.

The information that patients are given about treatment and care should be culturally appropriate and also appropriate to the patient’s level of education or understanding. It should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family and/or caregiver

involvement should be considered if appropriate.

The systematic review (SR) conducted for the update of this CPG encompassed intervention studies (primarily randomized controlled trials [RCTs]) and observational studies published between December 1, 2006 and October 21, 2016 and targeted nine key questions (KQs) focusing on the means by which the delivery of healthcare could be optimized for patients with LBP. Because a comprehensive review of the evidence related to LBP was not feasible, the nine selected KQs were prioritized from many possible KQs.

The section on Recommendations delineates whether or not the current CPG recommendations were based on an updated evidence review. Appendix E delineates whether the 2007 CPG recommendations

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were categorized based on an updated evidence review or whether the evidence support is from the previous version of the guideline. The section on Recommendation Categorization further describes the methodology used for the categorization.

B. Methods

The current document is an update to the 2007 VA/DoD LBP CPG. The methodology used in developing the 2017 LBP CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from

http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (Champions) and other subject matter experts from within the VA and DoD, known as the Work Group, and ultimately, the development and submission of an updated LBP CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified four clinical leaders, Sanjog Pangarkar, MD and Friedhelm Sandbrink, MD from the VA and MAJ Adam Bevevino, MD and MAJ Daniel Kang, MD from the DoD, as Champions for the 2017 LBP CPG.

The Champions and the Work Group for this CPG were charged with developing evidence-based clinical practice recommendations, and writing and publishing a guideline document to be used by providers within the VA and DoD healthcare systems. Specifically, the Champions and the Work Group were responsible for identifying the KQs – those considered most clinically relevant, important, and

interesting with respect to the diagnosis and management of patients with LBP. The Champions and the Work Group also provided direction on inclusion and exclusion criteria for the evidence review and assessed the level and quality of the evidence. The amount of new scientific evidence that had

accumulated since the previous version of the CPG was taken into consideration in the identification of the KQs. In addition, the Champions assisted in:

• Identifying appropriate disciplines of individuals to be included as part of the Work Group

• Directing and coordinating the Work Group

• Participating throughout the guideline development and review processes

The Lewin Team, including The Lewin Group, Duty First Consulting, ECRI Institute, and Sigma Health Consulting, LLC, was contracted by the VA and DoD to support the development of this CPG and conduct the evidence review. The first conference call was held in June 2016, with participation from the

contracting officer’s representative (COR), leaders from the VA Office of Quality, Safety and Value and the DoD Office of Evidence Based Practice, and the Champions. During this call, participants discussed the scope of the guideline initiative, the roles and responsibilities of the Champions, the project timeline, and the approach for developing and prioritizing specific research questions on which to base an SR about the diagnosis and treatment of LBP. The group also identified a list of clinical specialties and areas of expertise that were important and relevant to the diagnosis and treatment of LBP, from which Work Group

members were recruited. The specialties and clinical areas of interest included: chiropractic care,

integrative medicine, neurology, nursing, pain medicine, pharmacy, physical medicine and rehabilitation,

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The guideline development process for the 2017 LBP CPG update consisted of the following steps:

1. Formulating and prioritizing evidence questions (KQs) 2. Conducting the systematic review of the literature

3. Convening a face-to-face meeting with the CPG Champions and Work Group members 4. Drafting, revising, and submitting a final CPG about the diagnosis and treatment of LBP to the

VA/DoD EBPWG

Appendix A provides a detailed description of each of these tasks.

a. Grading Recommendations

The Champions and Work Group used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to assess the quality of the evidence base and assign a grade for the strength for each recommendation. The GRADE system uses the following four domains to assess the strength of each recommendation:[10]

• Balance of desirable and undesirable outcomes

• Confidence in the quality of the evidence

• Patient or provider values and preferences

• Other implications, as appropriate, e.g.,:

 Resource use

 Equity

 Acceptability

 Feasibility

 Subgroup considerations

Using this system, the Champions and the Work Group determined the direction (for or against) and relative strength (strong or weak) of each recommendation.[10] The direction indicates that the desirable effects of the recommendation outweigh the undesirable effects of the recommendation (for) or that the opposite is true (against). The strength indicates the Work Group’s level of confidence in the balance of desirable and undesirable effects of the recommendation among the intended patient population.[11] A strong recommendation indicates the Work Group is confident in this balance (e.g., that the desirable effects outweigh the undesirable effects). A weak recommendation indicates that the balance is still likely, but the Work Group’s confidence in the balance is lower than for a strong recommendation.

Occasionally, instances may occur when the Work Group feels there is insufficient evidence to make a recommendation for or against a particular therapy or preventive measure. This can occur when there is an absence of studies on a particular topic that met evidence review inclusion criteria, studies included in the evidence review report conflicting results, or studies included in the evidence review report

inconclusive results regarding the desirable and undesirable outcomes.

Using these elements, the grade of each recommendation is presented as part of a continuum:

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• Strong For (or “We recommend offering this option …”)

• Weak For (or “We suggest offering this option …”)

• No recommendation for or against (or “There is insufficient evidence …”)

• Weak Against (or “We suggest not offering this option …”)

• Strong Against (or “We recommend against offering this option …”)

The grade of each recommendation made in the 2017 LBP CPG can be found in the section on

Recommendations. Additional information regarding the use of the GRADE system can be found in the section on Grading Recommendations in Appendix A.

b. Reconciling 2007 Clinical Practice Guideline Recommendations

Evidence-based CPGs should be current, which typically requires revisions of previous guidelines based on new evidence or as scheduled, subject to time-based expirations.[12] For example, the United States Preventive Services Task Force (USPSTF) has a process for refining or otherwise updating its

recommendations pertaining to preventive services.[13] Further, the inclusion criteria for the National Guideline Clearinghouse specify that a guideline must have been developed, reviewed, or revised within the past five years.

The 2017 LBP CPG is an update of the 2007 LBP CPG. Thus, the content of the 2017 LBP CPG is reflective of the previous version of the CPG, but modified where necessary to reflect new evidence and new clinical priorities.

The Work Group focused largely on developing new and updated recommendations based on the evidence review conducted for the priority areas addressed by the KQs. In addition to those new and updated recommendations, the Work Group considered the current applicability of other

recommendations that were included in the previous 2007 LBP CPG without complete review of the relevant evidence, subject to evolving practice in today’s environment.

To indicate which recommendations were developed based on the updated review of the evidence versus recommendations that were carried forward from the 2007 version of the CPG, a set of recommendation categories was adapted from those used by the National Institute for Health and Care Excellence

(NICE).[14,15] These categories, along with their corresponding definitions, were used to account for the various ways in which older recommendations could have been updated. In brief, the categories took into account whether or not the evidence that related to a recommendation was systematically reviewed, the degree to which the recommendation was modified, and the degree to which a recommendation is relevant in the current patient care environment and within the scope of the CPG. Additional information regarding these categories and their definitions can be found in the section on Recommendation

Categorization. The categories for the recommendations included in the 2017 version of the guideline can be found in the section on Recommendations. The categorizations for each 2007 LBP CPG

recommendation can be found in Appendix E.

In cases where a 2007 LBP CPG recommendation was covered by a 2017 KQ, peer-reviewed literature

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CPG. Where new literature was considered when assessing the strength of the recommendation, it is referenced in the discussion following the corresponding recommendation, as well as in Appendix C.

The CPG Work Group recognizes that, while there are practical reasons for incorporating findings from a previous SR, previous recommendations, or recent peer-reviewed publications into an updated CPG, doing so does not involve an original, comprehensive SR and, therefore, may introduce bias.[16]

c. Peer Review Process

The CPG was developed through an iterative process in which the Work Group produced multiple drafts of the CPG. The process for developing the initial draft is described in more detail in Drafting and Submitting the Final Clinical Practice Guideline.

Once a near-final draft of the guideline was agreed upon by the Champions and the Work Group members, the draft was sent out for peer review and comment. The draft was posted on a wiki website for a period of 14 business days. The peer reviewers comprised individuals working within the VA and DoD health systems as well as experts from relevant outside organizations designated by the Work Group members.

External organizations that participated in the peer review included the following:

• Oregon Health & Science University

• Parker University

• Stanford Health Care

• University of California San Francisco School of Medicine

• Yale University

VA and DoD Leadership reached out to both the internal and external peer reviewers to solicit their feedback on the CPG. Reviewers were provided a hyperlink to the wiki website where the draft CPG was posted. For transparency, all reviewer feedback was posted in tabular form on the wiki site, along with the name of the reviewer. All feedback from the peer reviewers was discussed and considered by the Work Group. Modifications made throughout the CPG development process were made in accordance with the evidence.

C. Summary of Patient Focus Group Methods and Findings

When forming guideline recommendations, consideration should be given to the values of those most affected by the recommendations: patients. Patients bring perspectives, values, and preferences into their healthcare experience, and more specifically their pain care experience, that can vary from those of clinicians. These differences can affect decision making in various situations, and should thus be highlighted and made explicit due to their potential to influence a recommendation’s

implementation.[17,18] Focus groups can be used as an efficient method to explore ideas and perspectives of a group of individuals with an a priori set of assumptions or hypotheses and collect qualitative data on a thoughtfully predetermined set of questions.

Therefore, as part of the effort to update this CPG, VA and DoD Leadership, along with the LBP CPG Work Group, held a patient focus group prior to finalizing the KQs for the evidence review. The group met on September 7, 2016, at the William Beaumont Army Medical Center in El Paso, Texas. The aim of the focus

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group was to further the understanding of the perspectives of patients with LBP within the VA and/or DoD healthcare systems. The focus group explored a set of topics related to diagnosis and treatment of LBP, including knowledge of LBP and other pain treatment options, delivery of care, and the impact of and challenges with LBP.

It is important to note the focus group was a convenience sample and the Work Group recognizes the limitations inherent in the small sample size. Less than 10 people were included in the focus group consistent with the requirements of the federal Paperwork Reduction Act, 1980. The Work Group

acknowledges that the sample of patients included in this focus group may not be representative of all VA and DoD patients with LBP. Further, time limitations for the focus group prevented exhaustive exploration of all topics related to pain care in the VA and DoD and the patients’ broader experiences with their care.

Thus, the Work Group made decisions regarding the priority of topics to discuss at the focus group. These limitations, as well as others, were considered as the information collected from the discussion was used for guideline development. Recruitment for participation in the focus group was managed by the

Champions and VA and DoD Leadership, with assistance from coordinators at the facility at which the focus group took place.

The following concepts are ideas and suggestions about aspects of care that are important to patients and family caregivers and that emerged from the discussion. These concepts were needed and important parts of the participants’ care and added to the Work Group’s understanding of patient values and perspectives.

The Work Group considered the focus group feedback while assessing the strength of each

recommendation and continued to consider the feedback throughout the LBP CPG development process.

Additional details regarding the patient focus group methods and findings can be found in Appendix G.

LBP CPG Patient Focus Group Concepts

A. Consider patient-specific goals, values, and preferences and use shared decision making to develop a patient-centered plan for timely diagnosis, treatment, and lifestyle adaptation

B. Address strategies for pain management across all phases of treatment and educate patients about the use of pain medications, particularly opioids

C. Recognize the importance of communication and collaboration among providers of an interdisciplinary care team

D. Involve family caregivers to create support and motivation for patients with LBP

E. Work with providers to ensure continuity of care and ease of access to preferred providers F. Reduce the stigma experienced by patients with LBP

D. Conflict of Interest

At the start of this guideline development process and at other key points throughout, the project team was required to submit disclosure statements to reveal any areas of potential conflict of interest (COI) in the past 24 months. Verbal affirmations of no COI were also used as necessary during meetings

throughout the guideline development process. The project team was also subject to random web-based surveillance (e.g., ProPublica, CMS Open Payments).

If a project team member reported a COI (actual or potential), then it was reported to the Office of

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CPG Work Group determined whether or not action, such as restricting participation and/or voting on sections related to the conflict or removal from the Work Group, was necessary. If it was deemed necessary, action to mitigate the COI was taken by the Champions and Office of Evidence Based Practice, based on the level and extent of involvement. No conflicts of interest were identified for the LBP CPG Work Group members or Champions. Disclosure forms are on file with the Department of Veterans Affairs Evidence Based Practice Program office and available upon request.

E. Highlighted Features of this Clinical Practice Guideline

The 2017 edition of the VA/DoD LBP CPG is the first update to the original CPG. It provides practice recommendations for the diagnosis and treatment of populations with LBP. A particular strength of this CPG is the multidisciplinary stakeholder involvement from its inception, ensuring representation from the broad spectrum of clinicians engaged in the diagnosis and treatment of LBP.

The framework for recommendations in this CPG considered factors beyond the strength of the evidence, including balancing desired outcomes with potential harms of treatment, equity of resource availability, and the potential for variation in patient values and preferences. Applicability of the evidence to VA/DoD populations was also taken into consideration. A structured algorithm accompanies the guideline to provide an overview of the recommendations in the context of the flow of patient care and clinician decision making and to assist with training providers. The algorithm may be used to help facilitate translation of guideline recommendations into effective practice.

F. Patient-centered Care

VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[19] and improve treatment adherence.[20] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns.

As part of the patient-centered care approach, clinicians should review the outcomes of past treatment experiences and outcomes of possible future treatments with the patient. Additionally, they should involve the patient in prioritizing and setting specific goals regardless of the selected setting or level of care.

G. Shared Decision Making

Throughout this VA/DoD CPG, the authors encourage clinicians to focus on shared decision making (SDM). The SDM model was introduced in Crossing the Quality Chasm, an Institute of Medicine (now the National Academy of Medicine) report, in 2001.[21] It is readily apparent that patients with LBP,

together with their clinicians, make decisions regarding the type of treatment they choose to engage in;

however, these patients require sufficient information to be able to make informed decisions. Clinicians must be adept at presenting information to their patients regarding individual treatment plans and appropriate locations of care.

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H. Implementation

This CPG and algorithm are designed to be adapted by healthcare providers for the treatment of individual patients, bearing in mind patient-level considerations as well as local needs and resources. The algorithm serves as a tool to prompt providers to consider key decision points in the course of care.

Although this CPG represents the recommended practice on the date of its publication, medical practice is evolving and this evolution requires continuous updating based on published information. New technology and more research will improve patient care in the future. Identifying areas where evidence was lacking for the 2017 CPG can help identify priority areas for future research. Future studies

examining the results of LBP CPG implementation may lead to the development of new evidence particularly relevant to clinical practice.

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V. Guideline Work Group

Guideline Work Group*

Department of Veterans Affairs Department of Defense Sanjog Pangarkar, MD (Champion) MAJ Adam Bevevino, MD (Champion) Friedhelm Sandbrink, MD (Champion) MAJ Daniel Kang, MD (Champion)

David Cory Adamson, MD Curtis Aberle, RN, MSN, FNP

Francine Goodman, PharmD, BCPS MAJ Chris Allen, DPT, DSc, FAAOMPT Valerie Johnson, DC, DABCI Rachael Coller, PharmD, BCPS, BCPP

Mitchell Nazario, PharmD LTC Lisa Konitzer, PT, DSc, OCS, FAAOMPT Sandra Smeeding, PhD, CNS, FNP MAJ(P) Lex Mitchell, MD

Kirsten Tillisch, MD MAJ Jeremiah Samson, PT, ScD(C), OCS, COMT, FAAOMPT

Rebecca Vogsland, DPT, OCS LTC Jason Silvernail, DPT, DSc, FAAOMPT Evan Steil, MD, MBA, MHA Elaine P. Stuffel, BSN, MHA, RN Office of Quality, Safety and Value

Veterans Health Administration Office of Evidence Based Practice U.S. Army Medical Command Eric Rodgers, PhD, FNP, BC

James Sall, PhD, FNP-BC Rene Sutton, BS, HCA

Corinne K. B. Devlin, MSN, RN, FNP-BC Elaine P. Stuffel, BSN, MHA, RN

Lewin Group ECRI Institute

Clifford Goodman, PhD Christine Jones, MS, MPH, PMP

Jacqlyn Witmer Riposo, MBA Nicolas Stettler-Davis, MD, MSCE

Jonathan Treadwell, PhD Kristen E. D'Anci, PhD

Nancy Sullivan, BA Oluwaseun Akinyede, MPH

James Reston, PhD, MPH Joann Fontanarosa, PhD

Gina Giradi, MS Amy Tsou, MD Laura Koepfler, MLS Sigma Health Consulting, LLC

Frances Murphy, MD, MPH

*Additional contributor contact information is available in Appendix F.

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VI. Algorithm

This CPG follows an algorithm which is designed to facilitate understanding of the clinical pathway and decision-making process used in the diagnosis and treatment of LBP. The use of the algorithm format as a way to represent patient management was chosen based on the understanding that such a format may promote more efficient diagnostic and therapeutic decision making and has the potential to change patterns of resource use. Although the Work Group recognizes that not all clinical practices are linear, the simplified linear approach depicted through the algorithm and its format allows the provider to assess the critical information needed at the major decision points in the clinical process. It includes:

• An ordered sequence of steps of care

• Recommended observations and examinations

• Decisions to be considered

• Actions to be taken

For each guideline, there is corresponding clinical algorithm that is depicted by a step-by-step decision tree. Standardized symbols are used to display each step in the algorithm, and arrows connect the numbered boxes indicating the order in which the steps should be followed.[22]

Rounded rectangles represent a clinical state or condition.

Hexagons represent a decision point in the guideline, formulated as a question that can be answered Yes or No.

Rectangles represent an action in the process of care.

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Module A: Initial Evaluation of Low Back Pain

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Sidebar A: Diagnostic Work-up Possible causes

or conditions Red flags or risk factors on history or physical

examination Suggested diagnostic imaging

Cancer

History of cancer with new onset of LBP Unexplained weight loss

Failure of LBP to improve after 1 month Age > 50 years

Multiple risk factors present

Lumbosacral plain radiography For inconclusive results, advanced imaging such as MRI with contrast*

as appropriate

Infection

Fever

Intravenous drug use Recent infection Immunosuppression

MRI with contrast*

ESR

Fracture

History of osteoporosis Chronic use of corticosteroids Older age (≥75 years old) Recent trauma

Younger patients with overuse at risk for stress fracture

Lumbosacral plain radiography For inconclusive results, advanced imaging such as MRI^Ϯ, CT, or SPECT as appropriate

Ankylosing spondylitis

Morning stiffness

Improvement with exercise Alternating buttock pain

Awakening due to low back pain back pain during the second part of the night (early morning awakening) Younger age

Anterior-posterior pelvis plain radiography

Herniated disc

Radicular back pain (e.g., sciatica)

Lower extremity dysesthesia and/or paraesthesia

Positive straight-leg-raise test or crossed straight-leg-raise test

None

Severe/progressive lower extremity neurologic deficits

Symptoms present > 1 month MRI^Ϯ

Spinal stenosis

Radicular back pain (e.g., sciatica)

Lower extremity dysesthesia and/or paraesthesia Neurogenic claudication

Older age

None

Symptoms present > 1 month MRI^Ϯ

Cauda equina or conus medullaris syndrome

Urinary retention

Urinary or fecal incontinence Saddle anesthesia

Changes in rectal tone

Emergent MRI^Ϯ (preferred)

Abbreviations: CT: computed tomography; ESR: electron spin resonance; LBP: low back pain; MRI: magnetic resonance imaging;

SPECT: single-photon emission computed tomography

*MRI with contrast, except where contraindicated (e.g., renal insufficiency), otherwise MRI without contrast

ϮMRI, except where contraindicated, (e.g., patients with pacemakers), otherwise CT or CT myelogram

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Module B: Management of Low Back Pain

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Sidebar B: Interventions

Category Intervention

Low Back Pain Duration Acute

< 4 Weeks Subacute or Chronic

> 4 Weeks Self-care

Advice to remain active X X

Books, handout X X

Application of superficial heat X

Non-pharmacologic therapy

Spinal manipulation X

Clinician-guided exercise X

Acupuncture X

CBT and/or mindfulness-based stress

reduction X

Exercise which may include Pilates, tai

chi, and/or yoga X

Pharmacologic therapy

NSAIDs X X

Non-benzodiazepine skeletal muscle

relaxants X

Antidepressants (duloxetine) X

Other therapies Intensive interdisciplinary rehabilitation X

Abbreviations: CBT: cognitive behavioral therapy; NSAIDs: nonsteroidal anti-inflammatory drugs

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VII. Discussion of Recommendations A. Diagnostic Approach

Recommendation

1. For patients with low back pain, we recommend that clinicians conduct a history and physical examination, that should include identifying and evaluating neurologic deficits (e.g.,

radiculopathy, neurogenic claudication), red flag symptoms associated with serious underlying pathology (e.g., malignancy, fracture, infection), and psychosocial factors.

(Strong for | Reviewed, Amended) Discussion

Conducting a history and physical examination is considered standard practice and the cornerstone of clinical decision making. The vast majority of patients initially presenting with LBP experience self-limited episodes with substantial improvement of symptoms within the first month.[23-25] However, a small proportion of LBP may be caused by a specific underlying condition (e.g., malignancy 0.7%, infection 0.01%, vertebral compression fracture 4%, spinal stenosis 3%, symptomatic herniated disc 4%),[26]

including the possibility of referred pain from a proximate organ system (e.g., pancreatitis, nephrolithiasis, aortic aneurysm, endocarditis). Clinicians should also consider referred pain from the sacroiliac joint, hip joint or trochanteric bursa, which can sometimes manifest as LBP. LBP could also be a manifestation of a systemic condition (e.g., ankylosing spondylitis, rheumatoid arthritis) or multifocal underlying pain disorders (e.g., in patients with myofascial pain or fibromyalgia) that might be missed by addressing individual pain regions in isolation. Therefore, when evaluating LBP, clinicians should use a whole person approach and ask about the location of pain, frequency of symptoms, duration of pain, as well as any history of previous symptoms, treatment, response to treatment, and also evaluate psychosocial factors.

Clinicians should specifically identify the presence, duration, progression, and severity of neurologic symptoms and inquire about red flag symptoms. Rapidly progressive or severe neurologic deficits or LBP associated with a serious underlying condition (e.g., malignancy, fracture, infection, cauda equina

syndrome [CES]) may necessitate additional diagnostic workup and prompt treatment.[26] The confidence in available evidence was rated moderate regarding the utility of red flag symptoms to determine the likelihood of two serious underlying conditions (malignancy and fracture). There was insufficient evidence regarding the utility of red flag symptoms for identifying other serious underlying conditions; however, when assessing the strength of the recommendation, the Work Group also considered that the benefits far outweigh potential harms to the patient.

A recent SR, which was rated fair quality and included 14 studies of 14,860 patients with acute LBP, analyzed red flag symptoms for malignancy and fracture.[27] A history of malignancy was the only red flag with significantly increased probability (7% in primary care and 33% in emergency setting) of malignancy as the serious underlying condition for LBP. Other risk factors for malignancy, including unexplained weight loss, failure to improve after one month, and age greater than 50 years, had a post-test probability below 3%.[27] In patients with any one of the other three risk factors, the likelihood of cancer increased to approximately 1.2%.[28]

The evidence review also identified a study that included 669 patients and used a multivariate analysis to

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investigate red flag symptoms for fracture.[29] Data from the multivariate analysis suggests the following red flags for fracture: (1) older age (≥75 years old), (2) recent trauma, (3) osteoporosis, (4) severe back pain score ≥7 out of 10, and (5) thoracic pain. The evidence also suggests that the presence of multiple red flags increases the probability of fracture to between 42% and 90%.[29]

Red flag symptoms of LBP associated with infection have not been well studied, but may include fever, intravenous drug use, or recent infection.[26] CES is a rare condition, typically from an acute massive midline disc herniation, with an estimated prevalence of 0.04% among patients presenting with LBP. The most frequent finding in CES is urinary retention (90% sensitivity), although the constellation of symptoms may include: severe/progressive bilateral radiating leg pain, severe/progressive neurologic deficits at more than one level, saddle anesthesia, and fecal incontinence. In patients without urinary retention, the probability of CES is approximately 1 in 10,000.[28]

The Work Group felt a “Strong for” recommendation was warranted because the benefits of identifying serious underlying pathology outweigh the harms. The main benefit is the identification of a specific condition that requires a different treatment approach targeted at the underlying condition. The harms are the potential false positive red flag symptoms that may cause unnecessary additional diagnostic workup and the inherent risks and increased costs with those modalities, plus the fear or anxiety that may be experienced by the individual when undergoing diagnostic testing. The quality of evidence was

moderate regarding the utility of red flag symptoms to determine the likelihood of malignancy and fracture, but was insufficient regarding other serious underlying conditions. Patients and providers have similar values, as both groups highly value and would likely choose to identify a possible serious underlying pathology to optimize outcomes.

Feasibility does not seem to be a major hurdle, given that clinicians perform a history and physical exam as standard practice, and a practical approach may be a screening questionnaire for patients presenting with LBP to reduce the possibility of overlooking neurologic deficits or red flag symptoms. However, the second order consequence on resource burden may be from false positive red flag symptoms, and the over-ordering of additional diagnostic workup for patients with axial LBP. Additional areas of research include utility of red flag symptoms for infection as a serious underlying condition given the potential response to early treatment, as well as predictive modeling to help identify specific causes of LBP based on patient factors.

Recommendation

2. For patients with low back pain, we suggest performing a mental health screening as part of the low back pain evaluation and taking results into consideration during selection of treatment.

(Weak for | Reviewed, New-replaced) Discussion

Available evidence indicates that the existence of behavioral health disorders such as depression, anxiety, and posttraumatic stress disorder (PTSD) influence pain and outcomes for those with chronic LBP. For adults with LBP, there is evidence indicating a greater risk of developing chronic LBP when associated with the existence of pre-pain major depressive disorder or generalized anxiety disorder.[30] A VA study

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reported that 51% of patients with chronic LBP had PTSD symptoms.² An SR of fair quality included 17 studies that showed that symptoms of depression at baseline are related to worse LBP outcomes.[31]

Patients with depression showed greater pain interference, lower quality of life, more sleep problems, and greater functional disability than the non-depressed patients.[32] It appears that screening is appropriate in patients with acute, subacute, or chronic LBP.

The VA/DoD CPG for The Management of Major Depressive Disorder³ recommends patients not currently receiving treatment be screened for depression with the Patient Health Questionnaire-2 (PHQ-2). For those with a diagnosis of depression, the Patient Health Questionnaire-9 (PHQ-9) can be used as a quantitative measure of depression severity.

When assessing the strength of the recommendation, the Work Group considered that there are important benefits of mental health screening that outweigh the potential harms of not identifying LBP that is linked to or exacerbated by a coexisting mental health condition. Providers should be sensitive to the large variation of patient preferences, as some patients may worry that there is stigma attached to mental health conditions. Future research is needed on whether or not patients with co-occurring LBP and mental health conditions who are treated for their mental health conditions have improvement in the progression of their LBP over time.

Recommendation

3. For patients with acute axial low back pain (i.e., localized, non-radiating), we recommend against routinely obtaining imaging studies or invasive diagnostic tests.

(Strong against | Reviewed, Amended) Discussion

Patients presenting with less than three months of back pain, that is centered within the lumbar spine (i.e., axial LBP) and does not extend beyond the lower back, do not benefit from routine plain radiographs, computed tomography (CT), magnetic resonance imaging (MRI), or invasive diagnostic testing (discograms and other diagnostic injections).[26,33-37] There is moderate confidence in the quality of evidence to support this recommendation.

This patient population should be distinguished from those with chronic LBP and those with radiating pain.

The timeline for distinguishing patients with acute, sub-acute, and chronic LBP is difficult to define based on available evidence. While not absolute, we describe acute and sub-acute symptoms as those that have lasted for less than three months, and it is for this population that the recommendation is intended.

Axial/non-radiating LBP is centered within the lower back (mid-spinal or para-spinal) and extends in a lateral direction into the ipsilateral and contralateral para-spinal muscle regions. This is distinctly different from radiating back pain, in which patients endorse symptoms that radiate outside of the lower back region and into the lower extremities.

2 See the VA National Center for PTSD Guide for Patients on Chronic Pain and PTSD:

https://www.ptsd.va.gov/public/problems/pain-ptsd-guide-patients.asp

3 See the VA/DoD Clinical Practice Guideline for the Management of Major Depressive Disorder. Available at:

http://www.healthquality.va.gov/guidelines/MH/mdd/

VA/DoD CLINICAL PRACTICE GUIDELINE FOR DIAGNOSIS AND TREATMENT OF LOW BACK PAIN

DIAGNOSIS AND TREATMENT OF LOW BACK PAIN

The Diagnosis and Treatment of Low Back Pain Work Group

The Office of Quality, Safety and Value, VA, Washington, DC

&

Office of Evidence Based Practice, U.S. Army Medical Command

Table of Contents

I. Introduction

II. Recommendations

III. Background

A. Description of Low Back Pain

B. Epidemiology and Impact

IV. About this Clinical Practice Guideline

A. Scope of this Clinical Practice Guideline

B. Methods

C. Summary of Patient Focus Group Methods and Findings

D. Conflict of Interest

E. Highlighted Features of this Clinical Practice Guideline

F. Patient-centered Care

G. Shared Decision Making

H. Implementation

V. Guideline Work Group

VI. Algorithm

Module A: Initial Evaluation of Low Back Pain

Module B: Management of Low Back Pain

VII. Discussion of Recommendations A. Diagnostic Approach